Why It Matters

Gaps in the Food and Drug Administration's (FDA) policies for auditing outside medical device reviewers could allow organizations to continue reviewing devices for months while not complying with program standards, according to a new report from the U.S. Government Accountability Office (GAO) published Sept. 21. FDA has not established target time frames for completing audits or communicating findings to Third Party Review Organizations, and GAO found that some recent audits identifying deficiencies took six months or longer to resolve.

Third-party reviews provide recommendations to FDA about whether devices should be allowed on the market and made available for patient use. The devices are selected low-to-moderate risk products, including diagnostic ultrasound systems and surgical lasers, reviewed under FDA's Third Party Review Program, a voluntary alternative pathway intended to facilitate faster reviews.

The Big Picture

GAO found that FDA's audit policies are missing key details. The policies do not document the criteria FDA officials said they use to prioritize organizations for audits, contain outdated information about post-audit practices and do not establish target time frames for completing audits and communicating findings. GAO found that without those details, FDA risks allowing third parties to continue reviewing medical device submissions for extended periods while not complying with program standards.

FDA's Center for Devices and Radiological Health (CDRH) administers the program, under which device sponsors contract with FDA-accredited third parties to conduct the initial review of certain premarket applications, known as 510(k) submissions, before agency officials make the final marketing decision. The Food and Drug Administration Modernization Act of 1997 created the program. Since its inception, FDA has accredited 32 third parties to participate; as of May, nine held active accreditations.

From fiscal years 2018 through 2025, third parties provided FDA with 617 510(k) submission reviews and recommendations, accounting for about 2% of CDRH's annual 510(k) submission reviews. FDA officials said the program received $14 million to support staff, programs and activities for fiscal years 2018 through 2022 and spent approximately $6 million during that period. The remaining $8 million was carried over for program operations in fiscal years 2023 through 2027.

Broader Context

FDA is required to audit third parties periodically to ensure they remain in compliance with program standards. The agency conducted 25 periodic audits from 2000 through 2026, clustered in four phases: 13 from 2000 through 2003, five from 2011 through 2013, two in 2022 and five from 2025 through 2026. GAO found that the frequency of those audits was consistent with the statutory requirement to periodically audit third parties, although audits were conducted less regularly before FDA issued guidance in 2024 defining periodic audits as occurring at least once every three years.

As of May, four accredited third parties had never been audited. Two were accredited in 2026 and must be audited within three years under FDA guidance. The other two were accredited in 2017 and 2020 but had not conducted any 510(k) reviews as of June. FDA officials told GAO that auditing organizations that had not conducted any reviews would not provide meaningful information about their performance.

GAO also found examples showing why the timing of post-audit action matters. Following a 2022 audit, CDRH took five months to formally communicate findings and request corrective action from a third party. During that period, GAO said the organization could have continued operating while not complying with program standards, including a requirement intended to prevent the same product specialist from conducting both the initial and final reviews of a 510(k) submission. Two of three audits conducted in 2025 were not closed until June, and another remained open at the time of GAO's review.

The Bottom Line

The Consolidated Appropriations Act, 2023, included a provision directing GAO to report on the Third Party Review Program. GAO conducted the review for the Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee.

GAO recommended that the FDA commissioner should update the agency's audit policies to include existing criteria for selecting third parties for audits, reflect current post-audit practices, and establish target time frames for completing audits and communicating findings to Third Party Review Organizations. The Department of Health and Human Services (HHS) concurred with the recommendation. HHS said it would update its policies to provide staff with clear guidance on selecting third parties for audits and clarify procedures and time frames for audit review and closure. The recommendation remains open.

Until FDA updates its policies, GAO found that the agency risks allowing third parties to review 510(k) submissions for extended periods while not complying with program standards as FDA finalizes audit findings. Updating the policies would strengthen FDA's oversight and help ensure organizations continue meeting the accreditation standards required to review medical device submissions.

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